Fuzheng Yiliu-1010

Phase 2

Recruiting

• Conditions: Colorectal Cancer Stage II and III
• Interventions: Drug: Fuzheng Yiliu Formulation

• Registration Number: NCT04459754
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary

Real world study was used to evaluate the therapeutic effect of Fuzheng anti-tumor therapy on colorectal cancer patients in stage II and III after surgery and standard chemotherapy, and the prediction model of dominant population of Fuzheng anti-tumor therapy was constructed by using real-world data and gene expression profile data.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-29
• Status Verified: 2020-07
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-02
• Last Update Submitted: 2020-07-02
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Primary Completion: 2021-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

1. The age of the patients was 18-75 years old;
2. Radical resection of colorectal cancer (negative margin) was performed;
3. Patients with stage II high risk and stage III colorectal cancer confirmed by histology;
4. No liver, peritoneal or distant metastasis was found;
5. Patients with colorectal cancer who received standard chemotherapy or radiotherapy after operation and had no recurrence or metastasis at the end of radiotherapy and chemotherapy;
6. ECoG (Eastern Cooperative Oncology Group) score was 0-1; KPS score was 70 or above;
7. Liver function: SGOT and SGPT were less than 1.5 times of normal value, bilirubin was less than 1.5 mg / dl;
8. Renal function: creatinine < 1.8mg/dl.

Exclusion Criteria

1. Allergic to the drug of this scheme;
2. Pregnant or lactating women with fertility requirements during the study period;
3. Severe hypertension, coronary heart disease, diabetes and so on, which are under control for half a year due to cardiovascular accident and poor drug control, are accompanied with other uncontrollable benign diseases such as lung, kidney, liver, infection, etc;
4. Participate in other studies before and during treatment;
5. There was a history of other malignant tumors or multi-source tumors within one year;
6. Chronic hepatitis B or C (high copy viral DNA) or activity in HIV infection history or active phase;
7. Patients with tuberculosis or seizures who need to be treated (e.g. steroids or antiepileptic therapy).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fuzheng Yiliu group	Fuzheng Yiliu Formulation	-

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	3 years

Trial Locations

Locations (1)

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China